Healthcare Industry News: S.A.
News Release - July 15, 2008
Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for Israel
SOMERSET, N.J., July 15 (HSMN NewsFeed) -- Alfacell Corporation (NaS.A.: ACEL ) today announced that it has entered into a distribution agreement with Megapharm Ltd., a leading pharmaceutical company in IS.A.l, for the commercialization of ONCONASE® (ranpirnase) in IS.A.l. ONCONASE, the company's lead drug candidate, recently completed an international confirmatory Phase IIIb clinical trial for unresectable malignant mesothelioma (UMM).Under the agreement, Alfacell has granted Megapharm exclusive rights in the defined territory for the marketing, saleS.A.d distribution of ONCONASE. Alfacell will receive 50% of all sales in the territory. In addition, Alfacell will manufacture and supply the product to Megapharm, while Megapharm will be responsible for all activitieS.A.d costs related to regulatory filingS.A.d commercial activities in the territory.
Miron Drucker, CEO and founder of Megapharm, said, "Having been interested observers in the development of ONCONASE, a first-in-clasS.A.ti-cancer agent, we are proud to include this unique product in our oncology portfolio. We believe that ONCONASE will prove to be a promising new treatment option for patients suffering from mesothelioma."
"We are very pleased to add Megapharm to our growing list of important regional partners for ONCONASE," said Kuslima Shogen, chief executive officer of Alfacell. "Megapharm's role aS.A.leader in biotechnology marketing in IS.A.l provideS.A.facell with an ideal partner to maximize the potential of ONCONASE in this region. We look forward to a successful collaboration with Megapharm."
About ONCONASE®
ONCONASE iS.A.first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while S.A.ing normal cells. ONCONASE triggerS.A.optosis, the natural death of cells, via multiple molecular mechanisms of action.
Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.
ONCONASE has been granted fast track S.A.uS.A.d orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-S.A.e clinical trials. The product candidate, ONCONASE, iS.A. RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diS.A.es. Alfacell has completed Phase III clinical trials of ONCONASE in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related rolling New Drug Application, Alfacell is currently planning for Phase II clinical trials in other oncology indications. For more information, visit www.alfacell.com.
About Megapharm
Megapharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in IS.A.l with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. Megapharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in select therapeutic areas, and diversified segments of the healthcare business. The company also haS.A.recognized and proven track record for obtaining reimbursement and inclusion of its products in all the health funds in IS.A.l. For more information, visit www.megapharm.co.il.
Safe Harbor
This press release includes S.A.ements that may constitute "forward-looking" S.A.ements, uS.A.ly containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking S.A.ements involve riskS.A.d uncertainties that could cause actual results to differ materially from the forward-looking S.A.ements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainty whether the clinical trial results will allow the company to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will file or approve such application, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the company to finance reS.A.ch and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials or differences of opinion in interpreting the results of clinical trials, the company'S.A.ility to secure neceS.A.y approvals from regulatory agencies, dependence upon third-party vendors, the company'S.A.ility to timely regain its compliance with NAS.A. continued listing S.A.dardS.A.d maintain such compliance, and other risks discussed in the company's periodic filings with the SecuritieS.A.d Exchange Commission. By making these forward-looking S.A.ements, the company undertakes no obligation to update these S.A.ements for revisions or changeS.A.ter the date of this release.
Source: Alfacell
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